American export controls threaten to hinder global vaccine production

The world’s biggest vaccine-maker says it will feel the pinch in a month | Science & technology

4/18/2021 8:21:00 PM

Production lines in India making at least 160m doses of covid vaccine a month may soon come to halt

The world’s biggest vaccine-maker says it will feel the pinch in a month | Science & technology

LAST WEEK the billionth dose of covid-19 vaccine was produced. It is a sign of how greatly manufacturing capacity has expanded over the past six months that the next billion doses could be produced by May 27th, according to Airfinity, an analytics firm (see chart). Yet this ambition is at risk from American export controls on raw materials and equipment. Production lines in India, making at least 160m doses of covid vaccine a month, will come to a halt in the coming weeks unless America supplies 37 critical items.

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On April 16th, Adar Poonawalla, the chief executive of the Serum Institute of India (SII), the world’s biggest vaccine-maker, put out a tweet begging President Joe Biden to “lift the embargo of raw material exports out of the US...Your administration has the details”. Suresh Jadhav, SII’s executive director, says “we are absolutely concerned,” and that in the next four to six weeks the production of two vaccines will be affected: AstraZeneca’s, of which SII makes 100m doses a month, and Novavax’s, of which it expects to make 60m-70m doses a month. SII says it first alerted the American government to the impending problem two months ago.

That was shortly after the Biden administration announced, on February 5th, plans to use the Defence Production Act (DPA)—legislation that grants the president broad industrial-mobilisation powers—to bolster vaccine-making. This legislation has helped American pharmaceutical companies to secure raw materials and equipment needed to make more vaccines. But American firms that supply products essential to vaccine production say the DPA hinders their ability to export them. They must seek permission before exporting goods, which requires time and paperwork, and if America’s government decides they need the goods, firms may be barred from exporting them at all. Some are also concerned about pharma companies outside of America stockpiling goods because of concerns about delays caused by American export controls. Together, export controls and stockpiling risk gumming up the global supply chain.

Vaccine production requires an array of special materials, including plastic tubing, raw goods, filters and even paper. Because all these items have to be specially approved by regulators to be used in medicine production, finding substitutes quickly can be impossible.

SII is not the only company to be concerned. Export controls also affect European vaccine producers, who need special bags from America in which to make their products. At a vaccine supply-chain meeting in early March, one European pharmaceutical company complained of 66-week delivery times for the supply of bags, commenting that it would be quicker to make a steel container to manufacture them in.

On March 24th, Micheál Martin, Ireland’s prime minister, warned that export bans (and not just from America) would undermine global vaccine production, and noted that the Pfizer vaccine involves 280 components from 86 suppliers in 19 countries. Richard Hatchett, head of the Coalition for Epidemic Preparedness Innovations (CEPI), a global partnership to develop vaccines, says his organisation is “extremely concerned about constraints on global supply chains”.

CEPI is part of a new task force working with industry on this problem, and has also appealed to the World Trade Organisation for support. Its new head, Ngozi Okonjo-Iweala, held a high-level meeting this week, which concluded that stronger supply chains were critical to addressing global vaccine inequity.

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If all goes swimmingly, the world could produce as many as 14bn doses of vaccine this year. But if vaccines and raw materials do not arrive where and when needed, production will fall grievously short of that estimate. Shortfalls in India will hinder its own vaccination programme, which is ramping up amidst an alarming second wave of infections—the country is recording more than 1,000 deaths per day from covid-19. And since India has banned the export of finished vaccines while it serves domestic needs, Mr Jadhav says that SII cannot fulfill its commitments to Covax, a global vaccine-sharing programme, and cannot deliver supplies to Europe and Britain.

At a time when many American states have a surplus of vaccines, with as many as one in three doses going unused, American export restrictions are not just galling. They may soon derail the plan to vaccinate the world. Read more: The Economist »

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U.S. to Send Vaccine Materials to India Amid Unprecedented COVID SurgeThe Biden administration has suspended its rule to not share the vaccine as India reports hundreds of thousands of new cases each day. Mark my words, Joe Biden is “all hat and no cattle” when it comes to diplomacy. He will be responsible for another war soon!

U.S. Backs Waiver of Intellectual Property Protection for Covid-19 VaccinesThe Biden administration said it backs a World Trade Organization proposal for a temporary waiver of intellectual property protection for Covid-19 vaccines to help speed up global production. I am recently in your country, looking for new friends Need to waive lawsuit protection. As a “thank you” for Operation Warpspeed that provided for the vaccine at US and UK tax payer cost in the first place, the US is now allowed to give the vaccines away for free. Whatever happened to all the pledges from other countries?

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